BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 1780329 · Received July 26, 2010

    Report

    Report Number
    2249697-2010-00910
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    "PATIENT WAS EXPERIENCING COMPLICATIONS WITH HER METAL ON METAL HIP. ACCORDING TO THE SURGEON, IT LOOKED LIKE IT HAD TO DO WITH THE POSITION OF THE CUP. ONCE IN SURGERY, IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING METALLOSIS. BECAUSE OF THIS, THE PATIENT'S ABDUCTORS WERE GONE AND HER BONE QUALITY WAS POOR. SURGEON THAN DECIDED, HE NEEDED TO REMOVE THE CUP AND CEMENT IN A TRITANIUM. A FEW DAYS LATER DURING HER POST OP VISIT, PATIENT CONTINUED TO DISLOCATE. SURGEON ONCE AGAIN BROUGHT PATIENT BACK TO SURGERY AND THE POSITION OF THE CEMENTED CUP HAD CHANGED. SURGEON REMOVED CEMENTED CUP AND DECIDED TO DO A PRESSFIT TRITANIUM CUP ALONG WITH PLACEMENT OF SOME SCREWS TO BETTER FIXATE THE CUP FROM MOVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MJAX7D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R